scholarly journals Health Technology Assessment: confronto tra HD ed HDF on-line secondo i QALYs

2018 ◽  
Vol 23 (2) ◽  
pp. 29-32
Author(s):  
U. Tulli ◽  
E. Valeri
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Quality Adjusted Life Years ◽  
Sono Stati ◽  
Life Years ◽  
On Line ◽  
Quality Adjusted Life

Lo scopo di questo studio è valutare la qualità di vita percepita dalle persone sottoposte a terapia dialitica in rapporto al costoutilità; I pazienti oggetto dello studio a Tivoli sono stati 28, mentre a Guidonia sono stati 82. In base alla ricerca bibliografica abbiamo scelto di utilizzare l'ACU (analisi costo/utilità), tecnica che massimizza il rapporto utilità/costo, due alternative (interventi tecnici) in cui l'utilità è espressa in termini fisici e, in particolare, in termini di QALYs (quality adjusted life years) cioè anni di vita guadagnati ponderati per la qualità della vita per due diverse tecniche dialitiche: emodialisi standard HD ed emodiafiltrazione HDF. Osservando i dati emersi dallo studio ci siamo resi conto che i due gruppi percepiscono la qualità della loro vita in maniera molto simile, nonostante i parametri dialitici ed ematologici, oggetto di studio, siano significativamente migliori nel gruppo in trattamento dialitico con la metodica deU'Emodiafiltrazione.

scholarly journals INTELLIGENCE AND TRANSPARENCY IN HEALTH TECHNOLOGY ASSESSMENT

2016 ◽  
Vol 32 (1-2) ◽  
pp. 3-9 ◽  
Author(s):  
Henry S. Richardson
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Making ◽  
Health Technology ◽  
Quality Adjusted Life Years ◽  
Human Capabilities ◽  
Current Thinking ◽  
Life Years ◽  
Subjective Preference ◽  
Subjective Importance

Current thinking about the methodology of health technology assessment (HTA) seems to be dominated by two fundamental tensions: [1] between maintaining a tight focus on quality-adjusted life-years and broadening its concern out to pay attention to a broader range of factors, and [2] between thinking of the evaluative dimensions that matter as being objectively important factors or as ones that are ultimately of merely subjective importance. In this study, I will argue that health is a tremendously important all-purpose means to enjoying basic human capabilities, but a mere means, and not an end. The ends to which health is a means are manifold, requiring all those engaged in policy making to exercise intelligence in a continuing effort to identify them and to think through how they interrelate. Retreating to the subjective here would be at odds with the basic idea of HTA, which is to focus on certain objectively describable dimensions of what matters about health and to collect empirical evidence rigorously bearing on what produces improvements along those dimensions. To proceed intelligently in doing HTA, it is important to stay open to reframing and refashioning the ends we take to apply to that arena. The only way for that to happen, as an exercise of public, democratic policy making, is for the difficult value questions that arise when ends clash not to be buried in subjective preference information, but to be front-and-center in the analysis.

Health technology assessment and policy from the economic perspective

2004 ◽  
Vol 20 (1) ◽  
pp. 67-70 ◽  
Author(s):  
Frans Rutten
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Quality Adjusted Life Year ◽  
Decision Making Process ◽  
Economic Perspective ◽  
Cross Country ◽  
Evidence For Policy ◽  
Economic Considerations ◽  
Quality Adjusted Life

This article comments on the four country papers in this volume from an economic perspective. Different phases of the decision-making process, which can be supported by Health Technology Assessment (HTA), are considered. For each of these, there is large cross-country variation in the way in which HTA influences policy. Furthermore, economic themes regarding the relevance of HTA evidence for policy making, the position of cost-effectiveness in relation to other criteria vis-à-vis reimbursement decisions, the use of a cost per quality-adjusted life year threshold, and the incorporation of economic considerations in practice guidelines are discussed.

scholarly journals Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

2015 ◽  
Vol 19 (11) ◽  
pp. 1-138 ◽  
Author(s):  
James Raftery ◽  
Amanda Young ◽  
Louise Stanton ◽  
Ruairidh Milne ◽  
Andrew Cook ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Research ◽  
Health Technology ◽  
Classification Systems ◽  
Data Availability ◽  
Randomised Trials ◽  
Life Years ◽  
Randomised Controlled

BackgroundBy 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot ‘metadata’ on clinical trials funded by the HTA programme.ObjectivesThe aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.Data sourcesPublished monographs and internal HTA documents.Review methodsA database was developed, ‘populated’ using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.ResultsOne hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term ‘randomised trial’ in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.LimitationsThe study was limited by being confined to 125 randomised trials by one funder.ConclusionsMetadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here.FundingThe National Institute for Health Research HTA programme.

scholarly journals Interventions to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease: a cost-effective modelling review

2020 ◽  
Vol 24 (11) ◽  
pp. 1-150 ◽  
Author(s):  
Matt Stevenson ◽  
Lesley Uttley ◽  
Jeremy E Oakley ◽  
Christopher Carroll ◽  
Stephen E Chick ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cost Effective ◽  
Health Technology ◽  
Quality Adjusted Life Year ◽  
Expert Elicitation ◽  
Jakob Disease ◽  
Single Use ◽  
Quality Adjusted Life

Background Creutzfeldt–Jakob disease is a fatal neurological disease caused by abnormal infectious proteins called prions. Prions that are present on surgical instruments cannot be completely deactivated; therefore, patients who are subsequently operated on using these instruments may become infected. This can result in surgically transmitted Creutzfeldt–Jakob disease. Objective To update literature reviews, consultation with experts and economic modelling published in 2006, and to provide the cost-effectiveness of strategies to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease. Methods Eight systematic reviews were undertaken for clinical parameters. One review of cost-effectiveness was undertaken. Electronic databases including MEDLINE and EMBASE were searched from 2005 to 2017. Expert elicitation sessions were undertaken. An advisory committee, convened by the National Institute for Health and Care Excellence to produce guidance, provided an additional source of information. A mathematical model was updated focusing on brain and posterior eye surgery and neuroendoscopy. The model simulated both patients and instrument sets. Assuming that there were potentially 15 cases of surgically transmitted Creutzfeldt–Jakob disease between 2005 and 2018, approximate Bayesian computation was used to obtain samples from the posterior distribution of the model parameters to generate results. Heuristics were used to improve computational efficiency. The modelling conformed to the National Institute for Health and Care Excellence reference case. The strategies evaluated included neither keeping instruments moist nor prohibiting set migration; ensuring that instruments were kept moist; prohibiting instrument migration between sets; and employing single-use instruments. Threshold analyses were undertaken to establish prices at which single-use sets or completely effective decontamination solutions would be cost-effective. Results A total of 169 papers were identified for the clinical review. The evidence from published literature was not deemed sufficiently strong to take precedence over the distributions obtained from expert elicitation. Forty-eight papers were identified in the review of cost-effectiveness. The previous modelling structure was revised to add the possibility of misclassifying surgically transmitted Creutzfeldt–Jakob disease as another neurodegenerative disease, and assuming that all patients were susceptible to infection. Keeping instruments moist was estimated to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease cases and associated costs. Based on probabilistic sensitivity analyses, keeping instruments moist was estimated to on average result in 2.36 (range 0–47) surgically transmitted Creutzfeldt–Jakob disease cases (across England) caused by infection occurring between 2019 and 2023. Prohibiting set migration or employing single-use instruments reduced the estimated risk of surgically transmitted Creutzfeldt–Jakob disease cases further, but at considerable cost. The estimated costs per quality-adjusted life-year gained of these strategies in addition to keeping instruments moist were in excess of £1M. It was estimated that single-use instrument sets (currently £350–500) or completely effective cleaning solutions would need to cost approximately £12 per patient to be cost-effective using a £30,000 per quality-adjusted life-year gained value. Limitations As no direct published evidence to implicate surgery as a cause of Creutzfeldt–Jakob disease has been found since 2005, the estimations of potential cases from elicitation are still speculative. A particular source of uncertainty was in the number of potential surgically transmitted Creutzfeldt–Jakob disease cases that may have occurred between 2005 and 2018. Conclusions Keeping instruments moist is estimated to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease cases and associated costs. Further surgical management strategies can reduce the risks of surgically transmitted Creutzfeldt–Jakob disease but have considerable associated costs. Study registration This study is registered as PROSPERO CRD42017071807. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 11. See the NIHR Journals Library website for further project information.

scholarly journals Antidepressant medication to prevent depression relapse in primary care: the ANTLER RCT

2021 ◽  
Vol 25 (69) ◽  
pp. 1-62
Author(s):  
Larisa Duffy ◽  
Caroline S Clarke ◽  
Gemma Lewis ◽  
Louise Marston ◽  
Nick Freemantle ◽  
...  
Keyword(s):  
Primary Care ◽  
Confidence Interval ◽  
Antidepressant Medication ◽  
Health Technology ◽  
Quality Adjusted Life Years ◽  
Interview Schedule ◽  
Life Years ◽  
Term Maintenance ◽  
Quality Adjusted Life

Background There has been a steady increase in the number of primary care patients receiving long-term maintenance antidepressant treatment, despite limited evidence of a benefit of this treatment beyond 8 months. Objective The ANTidepressants to prevent reLapse in dEpRession (ANTLER) trial investigated the clinical effectiveness and cost-effectiveness of antidepressant medication in preventing relapse in UK primary care. Design This was a Phase IV, double-blind, pragmatic, multisite, individually randomised parallel-group controlled trial, with follow-up at 6, 12, 26, 39 and 52 weeks. Participants were randomised using minimisation on centre, type of antidepressant and baseline depressive symptom score above or below the median using Clinical Interview Schedule – Revised (two categories). Statisticians were blind to allocation for the outcome analyses. Setting General practices in London, Bristol, Southampton and York. Participants Individuals aged 18–74 years who had experienced at least two episodes of depression and had been taking antidepressants for ≥ 9 months but felt well enough to consider stopping their medication. Those who met an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, diagnosis of depression or with other psychiatric conditions were excluded. Intervention At baseline, participants were taking citalopram 20 mg, sertraline 100 mg, fluoxetine 20 mg or mirtazapine 30 mg. They were randomised to either remain on their current medication or discontinue medication after a tapering period. Main outcome measures The primary outcome was the time, in weeks, to the beginning of the first depressive episode after randomisation. This was measured by a retrospective Clinical Interview Schedule – Revised that assessed the onset of a depressive episode in the previous 12 weeks, and was conducted at 12, 26, 39 and 52 weeks. The depression-related resource use was collected over 12 months from medical records and patient-completed questionnaires. Quality-adjusted life-years were calculated using the EuroQol-5 Dimensions, five-level version. Results Between 9 March 2017 and 1 March 2019, we randomised 238 participants to antidepressant continuation (the maintenance group) and 240 participants to antidepressant discontinuation (the discontinuation group). The time to relapse of depression was shorter in the discontinuation group, with a hazard ratio of 2.06 (95% confidence interval 1.56 to 2.70; p < 0.0001). By 52 weeks, relapse was experienced by 39% of those who continued antidepressants and 56% of those who discontinued antidepressants. The secondary analysis revealed that people who discontinued experienced more withdrawal symptoms than those who remained on medication, with the largest difference at 12 weeks. In the discontinuation group, 37% (95% confidence interval 28% to 45%) of participants remained on their randomised medication until the end of the trial. In total, 39% (95% confidence interval 32% to 45%) of participants in the discontinuation group returned to their original antidepressant compared with 20% (95% confidence interval 15% to 25%) of participants in maintenance group. The health economic evaluation demonstrated that participants randomised to discontinuation had worse utility scores at 3 months (–0.037, 95% confidence interval –0.059 to –0.015) and fewer quality-adjusted life-years over 12 months (–0.019, 95% confidence interval –0.035 to –0.003) than those randomised to continuation. The discontinuation pathway, besides giving worse outcomes, also cost more [extra £2.71 per patient over 12 months (95% confidence interval –£36.10 to £37.07)] than the continuation pathway, although the cost difference was not significant. Conclusions Patients who discontinue long-term maintenance antidepressants in primary care are at increased risk of relapse and withdrawal symptoms. However, a substantial proportion of patients can discontinue antidepressants without relapse. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants and improve shared decision-making. The participants may not have been representative of all people on long-term maintenance treatment and we could study only a restricted range of antidepressants and doses. Identifying patients who will not relapse if they discontinued antidepressants would be clinically important. Trial registration Current Controlled Trials ISRCTN15969819 and EudraCT 2015-004210-26. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 69. See the NIHR Journals Library website for further project information.

scholarly journals Mapping clinical outcomes to generic preference-based outcome measures: development and comparison of methods

2020 ◽  
Vol 24 (34) ◽  
pp. 1-68 ◽  
Author(s):  
Mónica Hernández Alava ◽  
Allan Wailoo ◽  
Stephen Pudney ◽  
Laura Gray ◽  
Andrea Manca
Keyword(s):  
Cost Effectiveness ◽  
Linear Regression ◽  
Case Studies ◽  
Health Utility ◽  
Health Technology ◽  
Quality Adjusted Life Years ◽  
Indirect Methods ◽  
Direct Mapping ◽  
Life Years ◽  
Quality Adjusted Life

Background Cost-effectiveness analysis using quality-adjusted life-years as the measure of health benefit is commonly used to aid decision-makers. Clinical studies often do not include preference-based measures that allow the calculation of quality-adjusted life-years, or the data are insufficient. ‘Mapping’ can bridge this evidence gap; it entails estimating the relationship between outcomes measured in clinical studies and the required preference-based measures using a different data set. However, many methods for mapping yield biased results, distorting cost-effectiveness estimates. Objectives Develop existing and new methods for mapping; test their performance in case studies spanning different preference-based measures; and develop methods for mapping between preference-based measures. Data sources Fifteen data sets for mapping from non-preference-based measures to preference-based measures for patients with head injury, breast cancer, asthma, heart disease, knee surgery and varicose veins were used. Four preference-based measures were covered: the EuroQoL-5 Dimensions, three-level version (n = 11), EuroQoL-5 Dimensions, five-level version (n = 2), Short Form questionnaire-6 Dimensions (n = 1) and Health Utility Index Mark 3 (n = 1). Sample sizes ranged from 852 to 136,327. For mapping between generic preference-based measures, data from FORWARD, the National Databank for Rheumatic Diseases (which includes the EuroQoL-5 Dimensions, three-level version, and EuroQoL-5 Dimensions, five-level version, in its 2011 wave), were used. Main methods developed Mixture-model-based approaches for direct mapping, in which the dependent variable is the health utility value, including adaptations of methods developed to model the EuroQoL-5 Dimensions, three-level version, and beta regression mixtures, were developed, as were indirect methods, in which responses to the descriptive systems are modelled, for consistent multidirectional mapping between preference-based measures. A highly flexible approach was designed, using copulas to specify the bivariate distribution of each pair of EuroQoL-5 Dimensions, three-level version, and EuroQoL-5 Dimensions, five-level version, responses. Results A range of criteria for assessing model performance is proposed. Theoretically, linear regression is inappropriate for mapping. Case studies confirm this. Flexible, direct mapping methods, based on different variants of mixture models with appropriate underlying distributions, perform very well for all preference-based measures. The precise form is important. Case studies show that a minimum of three components are required. Covariates representing disease severity are required as predictors of component membership. Beta-based mixtures perform similarly to the bespoke mixture approaches but necessitate detailed consideration of the number and location of probability masses. The flexible, bi-directional indirect approach performs well for testing differences between preference-based measures. Limitations Case studies drew heavily on EuroQoL-5 Dimensions. Indirect methods could not be undertaken for several case studies because of a lack of coverage. These methods will often be unfeasible for preference-based measures with complex descriptive systems. Conclusions Mapping requires appropriate methods to yield reliable results. Evidence shows that widely used methods such as linear regression are inappropriate. More flexible methods developed specifically for mapping show that close-fitting results can be achieved. Approaches based on mixture models are appropriate for all preference-based measures. Some features are universally required (such as the minimum number of components) but others must be assessed on a case-by-case basis (such as the location and number of probability mass points). Future research priorities Further research is recommended on (1) the use of the monotonicity concept, (2) the mismatch of trial and mapping distributions and measurement error and (3) the development of indirect methods drawing on methods developed for mapping between preference-based measures. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 34. See the NIHR Journals Library website for further project information. This project was also funded by a Medical Research Council grant (MR/L022575/1).

OP08 National Institute for Health Research Health Technology Assessment Programme Research Funding And United Kingdom Burden Of Disease

2017 ◽  
Vol 33 (S1) ◽  
pp. 5-6
Author(s):  
Fay Chinnery ◽  
Gemma Bashevoy ◽  
Amanda Blatch-Jones ◽  
Lisa Douet ◽  
Sarah Puddicombe ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Burden Of Disease ◽  
Health Research ◽  
Data Exchange ◽  
Market Failure ◽  
Health Technology ◽  
Life Years ◽  
The Uk

INTRODUCTION:This study compared the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme portfolio of research with the united Kingdom (UK) burden of disease, as measured by Disability-Adjusted Life Years (DALYs).METHODS:Design: Cross-sectional study.Setting: The HTA Programme cohort included all funded applications (n = 363) received by the HTA Programme during the period 1 April 2011 to 31 March 2016. The sample contained primary research and evidence syntheses, all purely methodological studies were excluded since these are not comparable to the other study types.Main Outcome Measure: Proportion of spend for each of the twenty-one Health Research Classification System (HRCS) health categories were compared with burden of disease in the UK calculated using 2015 DALY data from the Institute for Health Metrics and Evaluation (IHME) Global Health Data Exchange (GHDx).RESULTS:The funded HTA Programme projects totalled about GBP397million research spend, which broadly reflected the UK DALY burden. Overall, there was less than 5 percent difference between the actual and predicted programme spend based on the burden of disease in the UK in most instances (seventeen out of the twenty-one HRCS Health Categories).The largest categories of apportioned spend were Cancer (accounting for 12.1 percent of portfolio), and Mental Health (11.8 percent of portfolio) which particularly reflected the 9.8 percent burden of disease to the UK. Most notable deviations from DALY, where spend was lower than disease burden, were in the Cancer, Cardiovascular and Musculoskeletal categories; which may reflect the importance of other, notably charity, funding.CONCLUSIONS:The HTA Programme spend broadly aligns with burden of disease as measured using DALYs. Discrepancies were expected owing to the programme remit and its approach to commissioning research to address market failure particularly in areas that are not already well supported by research charities or industry. Regular review of DALY data during research prioritisation and commissioning allows the HTA Programme to identify and address shortfalls in disease areas and to balance its portfolio.

Gli approcci alle valutazioni etiche nei processi di Health Technology Assessment

2008 ◽  
Vol 57 (2) ◽  
Author(s):  
Dario Sacchini ◽  
Pietro Refolo ◽  
Andrea Virdis
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Reflective Equilibrium ◽  
Health Technology ◽  
Coherence Analysis ◽  
European Network ◽  
Wide Reflective Equilibrium ◽  
Social Shaping Of Technology ◽  
Sono Stati ◽  
Social Shaping

Come emerge da uno studio, apparso nel 2007, dello European network for Health Technology Assessment (EUnetHTA), il quadro degli approcci attualmente utilizzati dalle varie agenzie per eseguire le valutazioni di tipo etico nei processi di Health Technology assessment (HTA), risulta abbastanza variegato. Oltre a quelli, per così dire “generali”, coma la Casistica, il Coerentismo, il Principalismo, il Modellamento sociale della tecnologia, l’Equilibrio riflessivo ampliato e l’Approccio interattivo-partecipativo alla valutazione delle tecnologie sanitarie, sono stati segnalati alcuni approcci locali, fra cui il Personalismo ontologicamente fondato. L’articolo intende effettuare una esplicitazione di questi approcci, cercando, al contempo, di integrarla con dei cenni sulla loro genesi, qualche spunto critico ed alcune osservazioni sulla loro applicazione nei processi di HTA. ---------- As noted by a research of the European network for Health Technology Assessment (EUnetHTA) published in 2007, the actually used approaches picture in different agencies to elaborate ethical analysis in health technology assessment (HTA) processes is enough variegated. Beyond the so-called “general” approaches, as Casuistry, Coherence analysis, Principlism, Social shaping of technology (SST), Wide reflective equilibrium (WRE) and Interactiveparticipatory HTA approach (iHTA), some local approaches have been indicated, among those there is the ontologically founded Personalism. The article intends to realize an explanation of these approaches, trying, at the same time, to integrate it with some notes on their genesis, some critical points and some observations on their application to HTA process.

OP141 Health Technology Assessment In India: Current Scenario And Way Forward

2020 ◽  
Vol 36 (S1) ◽  
pp. 1-2
Author(s):  
Komal Shah ◽  
Somen Saha ◽  
Priya Kotwani ◽  
Malkeet Singh ◽  
Kirti Tyagi
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Cochrane Library ◽  
Economic Evaluations ◽  
Healthcare Budget ◽  
Life Years ◽  
The Cost

IntroductionIndia has introduced health technology assessment (HTA) as a tool for improving the allocation of health resources. The core mandate of HTA in India (HTAIn) is to undertake critical appraisal of available technologies, identify cost-effective interventions, and help the government pursue evidence-informed decisions regarding public health expenditures. We conducted a systematic review to assess economic evaluation studies published in the last four years from India.MethodsEconomic evaluations published from September 2015 to September 2019 were identified by searching various databases, including PubMed, Scopus, Embase, The Cochrane Library, and CINAHL according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Cost-effectiveness studies and HTAs reported or conducted in India were included. Two independent reviewers performed the final selection of studies by assessing the full-text articles and conducted the data extraction. Differences of opinions were resolved through discussion and mutual consensus.ResultsAfter screening 2,837 articles, seventy met the inclusion criteria and were selected. The articles predominantly used secondary data (70%) to evaluate the cost effectiveness of an innovation. Among the technologies assessed, fifty-seven percent were curative in nature and most commonly addressed infectious diseases (27%), closely followed by non-communicable diseases, and maternal and child health. Principally, the cost effectiveness of a technology was expressed in terms of disability-adjusted or quality-adjusted life-years. Only two studies reported negative findings.ConclusionsHTA can play a pivotal role in equipping policy makers and public health payers to make appropriate decisions for healthcare budget allocations when mapped with the true disease burden of the population. It is important to highlight negative results and to create a national repository of HTA studies to facilitate faster adoption of best practices in India.

scholarly journals Time to Patients’ Access to New Medicines in Greece: Evaluation of Health Technology Assessment (HTA) Process from July 2018 until January 2021.

2021 ◽  
Author(s):  
Georgia Kourlaba ◽  
Alexandra Beletsi
Keyword(s):  
Health Technology Assessment ◽  
Median Time ◽  
Technology Assessment ◽  
Health Technology ◽  
Policy Makers ◽  
Positive List ◽  
Life Years ◽  
Long Time ◽  
Speed Up ◽  
Active Substances

Abstract Background: To present the outcome of the Health Technology Assessment (HTA) process in Greece from its onset back in July 2018 till January 2021 and to quantify the median time from marketing authorization (MA) to listing especially for new medicines. Methods: All products included in the reimbursement positive list from July 2018 to January 2021, were identified through the relevant Ministerial Decisions (MDs) posted on the website of the Ministry of Health (MoH) and the Positive Reimbursement Lists issued this period. The following information were collected for these medicines: date that MDs and Positive Reimbursement lists were issued, the legal basis of the initial MA, the MA date, the date of price registration, and the type of the HTA application. The time from MA to listing was calculated. Results: During the study period, 38 MDs were issued from which 35 (92%) were positive and resulted in the inclusion of 318 medicines and 3 (8%) were negatives that excluded 6 medicines. Focusing on new medicines, the median time from MA to listing was found to be 30 months with an interquartile range of 22 to 39 months. This time was statistically significantly shortened for FDC [19.3 (13-35) months], compared to biosimilars [26 (22-35) months, p=0.09] and on patent [38.5 (29-44) months, p=0.008]. For new generics, the corresponding median time was 22 (IQR: 12.5-31) months, statistically significantly lower than that of new medicines (p=0.028). Focusing on the four most common therapeutics areas, the median (IQR) time from MA to listing for new medicines was 28.3 (24.9–32.9) months and 34.9 (21.9-41.1) months, for oncologic and immunosuppressants (p=0.136), respectively, while on the field of cardiovascular and CNS there was no reimbursement of new active substances during the study period. Conclusions: This study showed that it takes a long time for Greek patients to get access to newly registered medicines. Given that the delay in access might result in potential loss of many life years, actions should be taken by policy makers to speed up patients access to new and innovative medicines.

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